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Authorisation of Biopharmaceuticals, Biosimilars and Advanced Therapies in Europe

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This 3-day training course focuses on the highly important contribution of biopharmaceuticals to new drug development. As the functions of biopharmaceuticals are fully explored and utilised, they will become increasingly relevant to the drug development community.

The course introduction provides an overview of both classical and biotechnology derived medicinal products and on the pathways used for scientific advice, clinical trials and marketing authorisations in Europe. The course will also cover in detail the particular requirements for the CMC section, comparability packages, and the important safety procedures required for infectious agents.

The particular aspects of the non-clinical and clinical development of biopharmaceuticals will be presented. A case study discussing how to develop a protein, without the relevant animal model, will also be examined. Case studies on monoclonal antibodies will illustrate the approach taken to identify benefit/risk ratio. An overview will be given on the most essential issues relating to ATMPs. A detailed presentation of the specific considerations for the development of biosimilar medicinal products, part of the EU provisions related to biopharmaceuticals, will be given during the course.

Key Topics

  • Definition and characteristics of biopharmaceuticals
  • Topics of particular relevance to biopharmaceuticals such as comparability, immunogenicity, adventitious safety, bioassay
  • ATMPs
  • Biosimilar medicinal products
  • Modules 3, 4 and 5 of the EU CTD of biopharmaceuticals
  • Regulatory pathways for scientific advice, clinical trials and marketing authorisations of biopharmaceuticals
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